Actively Recruiting
A Study to Assess the Effectiveness and Safety of IPN10200 Over Time in Adults With Moderate to Severe Wrinkle-like Lines Between the Eyebrows
Led by Ipsen · Updated on 2026-04-30
1300
Participants Needed
60
Research Sites
136 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to assess the effectiveness and safety of a single dose of IPN10200 compared to placebo (double-blind phase) and how well and safely repeat doses of IPN10200 work over time (open-label phase) in adult participants with moderate to severe glabellar lines. Glabellar lines are wrinkle-like lines that appear between the eyebrows and can become more noticeable with age or repeated facial expressions. They may affect a person's appearance and confidence. All participants in the double-blind phase will receive IPN10200 or placebo during the first treatment cycle. De novo participants in the open-label phase will receive IPN10200 during the first treatment cycle. Some participants may receive additional treatment cycles with IPN10200 depending on their eligibility. There will be 3 periods in this study: * A screening period (up to 20 days) to assess whether the participant can take part, requiring at least 1 visit to the study centre. * A treatment period where participants may receive up to 4 treatment cycles. In the double-blind phase, participants receive a single treatment of IPN10200 or placebo. In the open-label phase (rollover participants from double-blind), eligible participants may receive additional cycles of IPN10200. In the open-label phase (de novo participants), participants will receive IPN10200 in the first cycle and eligible participants may receive additional cycles of IPN10200. Requires multiple visits during the first month followed by 1 visit every month. * A follow-up period (24 weeks) after the last injection where participants' health will be monitored. Participants will undergo health measurements and observation, including blood sampling, physical examinations, clinical evaluations and electrocardiograms (ECG: recording of the electrical activity of heart). They will also be asked to fill in questionnaires and keep a diary. Each participant will be in this study for up to 107 weeks. Participants may withdraw consent to participate at any time.
CONDITIONS
Official Title
A Study to Assess the Effectiveness and Safety of IPN10200 Over Time in Adults With Moderate to Severe Wrinkle-like Lines Between the Eyebrows
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 18 years or older at consent
- Moderate or severe glabellar lines at maximum frown at baseline, assessed by validated 4-point scales
- Participants who are dissatisfied or very dissatisfied with their glabellar lines
- Female participants must use contraception according to local clinical study regulations
- Ability to give signed informed consent and comply with study requirements
- Ability and time to complete the study and follow instructions
- Not residing in an institution by administrative or court order
- Not a sponsor employee, clinical research staff, or immediate family member of such personnel
You will not qualify if you...
- Active infection or skin problems in the upper face including the glabellar region
- History of eyelid blepharoplasty, brow lift, or other upper facial surgery within 5 years
- History of facial nerve palsy
- Significant facial asymmetry, ptosis, excessive skin laxity, deep scarring, or thick sebaceous skin
- Closed-angle glaucoma or predisposition to it (Japan only)
- Medical conditions increasing risk with botulinum toxin exposure (e.g., myasthenia gravis)
- Scars, piercings, or tattoos near treatment area within 6 months or interfering with evaluations
- Use of botulinum toxin for any indication within 9 months before the study
- Prior treatment with IPN10200 in any study
- Use of medications affecting neuromuscular transmission within 30 days before baseline
- Use of aminoglycoside antibiotics within 30 days before baseline (except topical outside injection area)
- Use of systemic retinoids within 30 days before baseline or planned during study
- Prior permanent fillers, lifting threads, fat, or permanent procedures in the upper face
- Nonpermanent injectables in glabellar region within 12 months before baseline
- Facial aesthetic procedures such as photorejuvenation, lasers, or microneedling within 3 months before baseline
- Skin resurfacing or chemical peels within 12 months before baseline
- Planned cosmetic surgery or aesthetic procedures in the upper face during the study
- Past surgery in the glabellar area
- Use of therapies or treatments that may interfere with study evaluations
- Use of experimental drugs or devices within specified washout periods before the study
- Known positive for hepatitis B, hepatitis C, HIV, or diagnosis of AIDS
- Significant psychiatric disorders that may affect participation
- Inability to substantially lessen glabellar lines as judged by investigator
- Allergy or hypersensitivity to botulinum toxin or IPN10200 components
- History of chronic or recreational drug abuse
- Uncontrolled systemic disease or significant medical conditions that pose harm for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 60 locations
1
Rivkin Westside Aesthetics
Los Angeles, California, United States, 90025
Not Yet Recruiting
2
Clinical Testing of Beverly Hills
Los Angeles, California, United States, 91436
Actively Recruiting
3
Eye Research Foundation
Newport Beach, California, United States, 92663
Actively Recruiting
4
Steve Yoelin MD Medical Associates Inc
Newport Beach, California, United States, 92663
Actively Recruiting
5
Skin and Beauty Center
Pasadena, California, United States, 91105
Actively Recruiting
6
Dermatology Cosmetic Laser Medical Associates of La Jolla Inc.
San Diego, California, United States, 92121
Not Yet Recruiting
7
Southern California Dermatology, Inc.
Santa Ana, California, United States, 92701
Not Yet Recruiting
8
DMR Research, PLLC
Westport, Connecticut, United States, 06880
Actively Recruiting
9
Center for Dermatology and Dermatologic Surgery
Washington D.C., District of Columbia, United States, 20037
Not Yet Recruiting
10
Skin and Cancer Associates (SCA) and the Center for Cosmetic Enhancement (CCE) - Aventura
Aventura, Florida, United States, 33180
Actively Recruiting
11
Weinkle Dermatology
Bradenton, Florida, United States, 34209
Actively Recruiting
12
Skin Research Institute
Coral Gables, Florida, United States, 33146
Not Yet Recruiting
13
Miami Dermatology & Laser Research
Miami, Florida, United States, 33133
Actively Recruiting
14
Kavali Plastic Surgery and Skin Renewal Center
Atlanta, Georgia, United States, 30328
Actively Recruiting
15
DeNova Research
Chicago, Illinois, United States, 60610
Actively Recruiting
16
Chicago Cosmetic and Dermatologic Research
Chicago, Illinois, United States, 60654-5826
Actively Recruiting
17
Advanced Dermatology, A Forefront Dermatology Practice
Lincolnshire, Illinois, United States, 60069
Not Yet Recruiting
18
LASSI - Laser and Skin Surgery Center of Indiana
Indianapolis, Indiana, United States, 46260
Actively Recruiting
19
Coleman Center For Cosmetic Dermatologic Surgery
Metairie, Louisiana, United States, 70006
Not Yet Recruiting
20
DelRicht Research
New Orleans, Louisiana, United States, 70115
Actively Recruiting
21
Etre, Cosmetic Dermatology and Laser Center
New Orleans, Louisiana, United States, 70130
Actively Recruiting
22
Maryland Laser, Skin, & Vein Institute, LLC (MDLSV)
Hunt Valley, Maryland, United States, 21030
Actively Recruiting
23
Lawrence J. Green, MD. LLC
Rockville, Maryland, United States, 20850
Actively Recruiting
24
SkinCare Physicians
Chestnut Hill, Massachusetts, United States, 02467
Actively Recruiting
25
Michigan Center for Research Company
Clarkston, Michigan, United States, 48346
Actively Recruiting
26
Skin Specialists PC dba Schlessinger MD
Omaha, Nebraska, United States, 68144
Actively Recruiting
27
StracSkin
Portsmouth, New Hampshire, United States, 03801
Actively Recruiting
28
Rejuva Center at Williams
Latham, New York, United States, 12110
Actively Recruiting
29
The Center for Dermatology, Cosmetic & Laser Surgery
Mount Kisco, New York, United States, 10549
Actively Recruiting
30
Luxurgery
New York, New York, United States, 10021
Actively Recruiting
31
Dr. Z. Paul Lorenc MD, Office Of
New York, New York, United States, 10028
Actively Recruiting
32
Skin Search Of Rochester, Inc.
Rochester, New York, United States, 14623
Actively Recruiting
33
Rochester Dermatologic Surgery, P.C.
Victor, New York, United States, 14561
Not Yet Recruiting
34
Aesthetic Solutions P.A.
Chapel Hill, North Carolina, United States, 27517
Actively Recruiting
35
Dermatology, Laser & Vein Specialists of the Carolinas (DLVSC) - Charlotte Office
Charlotte, North Carolina, United States, 28207
Actively Recruiting
36
Nash Research Group, LLC
Powell, Ohio, United States, 43065
Actively Recruiting
37
Oregon Dermatology and Research Center
Portland, Oregon, United States, 97210
Actively Recruiting
38
Paddington Testing Company
Philadelphia, Pennsylvania, United States, 19103
Actively Recruiting
39
Brian S. Biesman MD, PLLC
Nashville, Tennessee, United States, 37203
Actively Recruiting
40
Tennessee Clinical Research Center
Nashville, Tennessee, United States, 37215
Actively Recruiting
41
Center for Clinical Studies
Webster, Texas, United States, 77598
Not Yet Recruiting
42
Sas Aimed
Lyon, France, 69006
Not Yet Recruiting
43
Institut Cyrnos
Nice, France, 6000
Not Yet Recruiting
44
Thinkin SAS
Paris, France, 75016
Not Yet Recruiting
45
Rosenpark Research GmbH
Darmstadt, Germany, 64283
Not Yet Recruiting
46
Privatpraxis Dr. Hilton & Partner
Düsseldorf, Germany, 40212
Not Yet Recruiting
47
Universitaet Hamburg - Institut fuer Biochemie und Molekularbiologie
Hamburg, Germany, 20146
Not Yet Recruiting
48
Derma Science GmbH
Hamburg, Germany, 22609
Not Yet Recruiting
49
Noahklinik- Klinik fuer Plastische Chirurgie
Kassel, Germany, 34117
Not Yet Recruiting
50
Dermatologische Gemeinschaftspraxis
Mahlow, Germany, 15831
Not Yet Recruiting
51
Skin Concept - Private Dermatology Practice
München, Germany, 80333
Not Yet Recruiting
52
Haut- und Lasercentrum Potsdam
Potsdam, Germany, 14467
Not Yet Recruiting
53
Akihabara Skin Clinic
Chiyoda-ku, Japan, 101-0021
Actively Recruiting
54
Medical Corporation Chiseikai - Tokyo Center Clinic
Chūōku, Japan, 103-0027
Actively Recruiting
55
Josui Dermatology Clinic
Fukuoka, Japan, 810-0022
Actively Recruiting
56
Clinica BellaForma
Minatoku, Japan, 107-0052
Actively Recruiting
57
Forest Palace Dermatology Clinic
Nerima-ku, Japan, 177-0041
Actively Recruiting
58
Kume Derma Clinic
Sakaishi, Japan, 593-8324
Actively Recruiting
59
Kotoni Tower Dermatology and Plastic Surgery
Sapporo, Japan, 063-0812
Actively Recruiting
60
Yoshikawa Skin Clinic
Takatsuki-shi, Japan, 569-0824
Actively Recruiting
Research Team
I
Ipsen Recruitment Enquiries
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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